MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X60MM CORT LOCK SCR STE; SCREW, PROSTHESIS

Catalog Number 856135060

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the distributorship that the product was nonconforming, as the sterile package had scratch marks on it.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g6, h2, h10 d10: item name: 3.5x60mm cort lock screw cat #: 856135060 lot# 942790 qty of 9 total multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02509; 0001825034 - 2022 - 02510; 0001825034 - 2022 - 02511; 0001825034 - 2022 - 02512; 0001825034 - 2022 - 02513; 0001825034 - 2022 - 02514; 0001825034 - 2022 - 02515; 0001825034 - 2022 - 02516.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 -visual inspection of the returned product found there is a scratch on the inner pouch on all 9 products.The scratch does not go through the pouch.Sterility has not been compromised.This complaint has been confirmed.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-a definitive root cause cannot be determined.- upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: 3.5X60MM CORT LOCK SCR STE
• Type of Device: SCREW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15713987
• MDR Text Key: 304029860
• Report Number: 0001825034-2022-02436
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868352058
• UDI-Public: (01)00887868352058(17)300729(10)942790
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856135060
• Device Lot Number: 942790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 12/05/2022
• Supplement Dates FDA Received: 11/10/2022; 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10